Description

Aripiprazole Related Compound (5-(4-Bromobutoxy)-3,4-Dihydroquinolin-2(1H)-One) is a key chemical intermediate and reference standard used in the development and quality control of active pharmaceutical ingredients (APIs). This high-purity compound is critical for ensuring the safety and efficacy of pharmaceutical products by serving as a benchmark for impurity profiling and analytical method validation. It is primarily utilized by research institutions, analytical laboratories, and pharmaceutical manufacturers focused on antipsychotic drug development and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of related substances in Aripiprazole API and finished dosage forms.
• Impurity Profiling: Essential for method development and validation in HPLC, UPLC, and LC-MS analyses to monitor and control process-related impurities.
• Process Chemistry Research: Serves as a critical intermediate or starting material in synthetic route development and optimization for novel chemical entities.
• Regulatory Compliance & Documentation: Supports the preparation of regulatory submission dossiers (e.g., for FDA, EMA) by providing definitive impurity characterization data.
• Quality Control Laboratories: Employed in routine batch release testing to ensure API purity meets pharmacopeial specifications (USP, EP).
• Stability Studies: Acts as a marker compound in forced degradation and long-term stability studies of Aripiprazole formulations.

Basic Information

Product Name	Aripiprazole Related Compound (5-(4-Bromobutoxy)-3,4-Dihydroquinolin-2(1H)-One)
CAS No.	63309-35-3
Molecular Formula	C₁₃H₁₆BrNO₂
Molecular Weight	298.18 g/mol
Synonyms	5-(4-Bromobutoxy)-3,4-dihydro-2(1H)-quinolinone; 5-(4-Bromobutoxy)-1,2,3,4-tetrahydro-2-quinolinone; Aripiprazole Impurity; Aripiprazole Related Substance; 2-Oxo-1,2,3,4-tetrahydroquinolin-5-yl 4-bromobutyl ether; 5-(4-Bromobutoxy)-3,4-dihydroquinolin-2(1H)-one; 1,2,3,4-Tetrahydro-5-(4-bromobutoxy)-2-quinolinone
EINECS	Contact for details

Quality Control

Our Aripiprazole Related Compound is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity assay, identity confirmation (IR, NMR), and residual solvent analysis, to ensure it meets stringent specifications for use as a reference standard. Certificates of Analysis (COA) with detailed chromatographic data are provided for traceability and regulatory support.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. This material is light-sensitive (store away from light).

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity ≤ 0.5% Total impurities ≤ 1.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5% w/w

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.